runabout>的读音ANNEX 17 附件17
Parametric Relea 参数放行
Table of Contents目录
1. Principle 原则
2. Parametric Relea参数放行
3. Parametric Relea for sterile products. 无菌产品的参数放行学生会主席竞选演讲稿
hanita4. Glossary术语
where is your heart
1. Principle原则
1.1 The definition of Parametric Relea ud in this Annex is bad on that propod by the European Organization for Quality: " A system of relea that gives the assurance that the product is of the intended quality bad on information collected during the manufacturi
ng process and on the compliance with specific GMP requirements related to Parametric Relea."
本附件中参数放行的定义，是根据欧洲质量组织提出的：“是根据生产过程中收集的信息和与GMP中与参数放行相关的要求相符合，保证产品达到预期的质量的放行系统”。
1.2. Parametric relea should comply with the basic requirements of GMP, with applicable annexes and the following guidelines.
参数放行要符合GMP的基本要求，符合其他相关的附件和以下原则。
2. Parametric relea参数放行上海世外
2.1. It is recognid that a comprehensive t of in-process tests and controls may provide greater assurance of the finished product meeting specification than finished product testing.
普遍认为，全面的一套过程控制和检验要比最终产品的检验，能够提供最终产品符合标准的更高的保证。
2.2. Parametric relea may be authorid for certain specific parameters as an alternative to routine testing of finished products. Authorisation for parametric relea should be given, refud or withdrawn jointly by tho responsible for asssing products together with the GMP inspectors.
参数放行是把一些特定的参数定义为替代最终产品检验的特定参数。参数放行的授予、拒绝或撤回要由负责产品评估的人和GMP检查人员共同核准。
3. Parametric relea for sterile products无菌产品的放行
3.1. This ction is only concerned with that part of Parametric Relea which deals with the routine relea of finished products without carrying out a sterility test. Elimination of the sterility test is only valid on the basis of successful demonstration that predetermined, validated sterilising conditions have been achieved.
本节只涉及进行正常放行不做无菌检查的参数放行部分。
免除无菌检验，是基于整个过程能有效地证明达到预先设定的和经过验证的灭菌条件。
3.2. A sterility test only provides an opportunity to detect a major failure of the sterility assurance system due to statistical limitations of the method.
无菌检验仅是提供由于方法上的统计缺陷所导致的无菌保证系统失效的一个检查方法。
3.3. Parametric Relea can be authorid if the data demonstrating correct processing of the batch provides sufficient assurance, on its own, that the process designed and validated to ensure the sterility of the product has been delivered.
只有在有数据表明产品的生产有充分的保证，生产工艺的设计和验证保证产品的无菌性时，参数放行才会被批准。
3.4. At prent Parametric relea can only be approved for products terminally sterilized in their final container.
目前参数放行仅批准应用于在最后容器内灭菌的终端灭菌产品。
3.5. Sterilization methods according to European Pharmacopeia requirements using steam, dry heat and ionising radiation may be considered for parametric relea.
按照欧洲药典的要求，蒸汽灭菌法、干热灭菌法和离子放射方法可以考虑采用参数放行。
3.6. It is unlikely that a completely new product would be considered as suitable for Parametric Relea becau a period of satisfactory sterility test results will form part of the acceptance criteria. There may be cas when a new product is only a minor variation, from the sterility assurance point of view, and existing sterility test data from other products could be considered as relevant.
troy的意思对一个新产品的生产一般不考虑采用参数放行，因为一段时间的理想的无菌检验结果是参数放行接受标准的一部分。例外的是那些从无菌保证方面变化很小，且其他产品的灭菌检验数据可以作为参考时的情况。
3.7. A risk analysis of the sterility assurance system focud on an evaluation of releasing non-sterilid products should be performed.
对无菌保证系统进行风险分析要针对未灭菌产品可能被放行的评估。合肥达内
3.8. The manufacturer should have a history of good compliance with GMP.
生产企业要有很好的符合GMP的历史记录。
3.9. The history of non sterility of products and of results of sterility tests carried out on the product in question together with products procesd through the same or a similar sterility assurance system should be taken into consideration when evaluating GMP compliance.
在进行符合GMP评估时，要进行综合考虑未灭菌产品和无菌检验结果有问题的历史记录，以及采用同样的无菌保证系统下生产的其他产品的问题，。聚英考研网
3.10. A qualified experienced sterility assurance engineer and a qualified microbiologist should normally be prent on the site of production and sterilization.
一般要有一名合格的有经验的灭菌保证质量工程师和一名合格的微生物师在生产和灭菌现场。
3.11. The design and original validation of the product should ensure that integrity can be maintained under all relevant conditions.
产品的设计和最初验证要保证在所有相关条件下产品的完整性。
3.12. The change control system should require review of change by sterility assurance personnel.
更改控制要求无菌保证人员复核相关更改。
3.13. There should be a system to control microbiological contamination in the product before sterilisation.
要有一个在灭菌之前控制产品中微生物污染的系统。
3.14. There should be no possibility for mix ups between sterilid and non sterilized products. Physical barriers or validated electronic systems may provide such assurance.
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